Cleared Special

K121878 - CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES

K121878 is an FDA 510(k) clearance for CARDIOBLATE CRYOFLEX SURGICAL ABLATION ..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 127-day FDA review.

K121878 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
127d
Days
Class 2
Risk

K121878 is an FDA 510(k) clearance for the CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121878

510(k) Number K121878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2012
Decision Date November 02, 2012
Days to Decision 127 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

OCL Device Classification - Class 2, Special Controls

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K121878.
ISOLATOR LINEAR PEN
K130521 · AtriCure, Inc. · Apr 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
K123733 · Medtronic, Inc. · Apr 2013
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K120857 · Ncontact Surgical, Inc. · Nov 2012
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · AtriCure, Inc. · Sep 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc. · Jun 2012
K121878 · CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
Download PDF FDA Summary Medtronic, Inc.